ULTRA Border
Basic Information
- Brand Name
- ULTRA Border
- Primary DI
- 00015961669227
- Version / Model
- 6"x6"
- Catalog Number
- 3000116879
- Company Name
- MILLIKEN HEALTHCARE PDTS, LLC
- Labeler DUNS
- 963905539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-06
- Public Version
- 2
- Public Version Date
- 2021-06-22
- Public Version Status
- Update
- Public Device Record Key
- 1d03a35f-98d7-4679-904f-99fdea30d63e
Device Description
ULTRA is a sterile, single use gentle adhesive foam wound dressing. ULTRA is indicated for low to highly exuding acute and chronic wounds such as partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV pressure ulcers, venous ulcers, and diabetic ulcers. The dressing has a gentle silicone border, a polyester/ nylon wound contact layer, polyurethane absorbent foam, and a moisture vapor permeable film outer layer. The film outer layer (side placed away from the wound) is tan printed with green. The print is a circle logo with"Milliken" above and "ULTRA" printed inside. The dressing is also printed with "this side away from wound," as well as a repeating set of symbols of an arrow, heart, and shield.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44970 | Exudate-absorbent dressing, non-gel, non-antimicrobial | A wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10015961669224 | GS1 | Shelf box | 10 | In Commercial Distribution | |
| Primary | 00015961669227 | GS1 | ||||
| Package | 20015961669221 | GS1 | Shipper box | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 18004326686
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Area/Surface Area | 36 | Square inch |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 131 Degrees Fahrenheit